Medline URO170714Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277866928), received between Dec 29, 2023 and Sep 30, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Fracture; Detachment of Device or Device Component

  It was reported that "While administering bladder chemo, on (b)(6) 2024, the side port of the indwelling foley catheter broke off."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948762 ↗
• MalfunctionDec 29, 2023Material Integrity Problem; Material Integrity Problem

  "BALLOON PORTION" OF FOLEY CATHETER MISSING AFTER FOLEY WAS "PLACED UNDER TENSION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418661 ↗